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Department of Paediatrics, Specialised Translational Research Oxford Neuromuscular Group (STRONG), John Radcliffe Hospital, Oxford
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**About the role** We have an exciting opportunity to join the Specialised Translational Research Oxford Neuromuscular Group (STRONG) in the Department of Paediatrics as our Clinical Trial Manager. You will play an important role in the delivery of our portfolio of clinical trials and will work closely with the Clinical Research and Operations Manager, Laura Chiverton and the Principle Investigator, Laurent Servais. You will be responsible for the management and delivery of a portfolio of clinical trials and will work closely with the research group to ensure efficient running of our clinical trials. The successful candidate will have excellent organisational and communication skills to facilitate smooth delivery of our clinical trials. You will be working in a growing department within the Medical Sciences Division. The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. This position is offered full-time on a fixed-term contract initially for one year or until 31 December 2025 (whichever is sooner) with the possibility to extend provided further external funding is available. **About the department** The Department of Paediatrics holds the Athena Swan Gold award (a national gender equality charter) acknowledging the innovative policies and practices developed across the department. We encourage staff to develop their skills by offering all staff ten paid days of professional development each year and have a policy where staff can apply to receive funding for further training courses to support their professional development. For staff on work visas, we also offer financial assistance towards visa renewal fees. Please visit our website to find out more about the Department. **About you** You will have experience in management of clinical trials and be educated to degree level, or have equivalent experience. The successful candidate will have knowledge of the regulatory and governance requirements for UK clinical trials. You will have highly effective verbal and written communication skills with all levels of staff and an ability to operate effectively in a demanding and growing research environment. **Application Process** You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Laura Chiverton, the Clinical Research and Operations manager. Only online applications received before 12.00 midday on 15th November 2024 will be considered. Interviews will be held as soon as possible thereafter. The Department of Paediatrics offers an Interview Expense Reimbursement Policy in its efforts towards equality, diversity and inclusion. Should you be invited to interview, we will share further information about the policy at that stage.
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Standard Grade 6: 34,982 - 40,855 with a discretionary range to £44,382 per annum (pro-rata)
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_________________________________________________________________________ Job description and selection criteria Job title Clinical Trial Manager Division Medical Sciences Department Paediatrics Location Department of Paediatrics, Specialised Translational Research Oxford Neuromuscular Group (STRONG), John Radcliffe Hospital, Oxford Grade and salary Grade 6: £34,982 - £40,855 per annum (with a discretionary range to £44,382 per annum) Hours Full time Contract type Fixed-term (for 12 months or until 31 December 2025, whichever is earliest) Reporting to Laura Chiverton, Clinical Research and Operations Manager Vacancy reference 176137 Additional information Applications are to be made online, please see the advert for the closing date. The role Based within the Specialised Translational Research Oxford Neuromuscular Group (STRONG) and working within a trial research team, you will have the responsibility for the delivery of a portfolio of clinical trials from set-up to closeout, ensuring quality in all areas of trial delivery. You will take the lead on a portfolio of clinical trials, undertaking all key tasks within the lifecycle of the trial. This will require you to work flexibly within your team as directed by the clinical research and operations manager. You will need to work effectively within the research team as well as using your own initiative to problem solve. The research team includes Research Nurses, Clinical Research Fellows, Physiotherapists, Project Managers, Data Manager and Quality Assurance Manager. The successful candidate will need to have effective communication and team work with the whole research team. Responsibilities • Manage at least one study budget or group budget as delegated by the Clinical Research and Operations Manager. • Develop and maintain excellent relationships with senior colleagues within the University and Department. • Ensure that all administrative procedures for the lifecycle of a clinical trial are completed and that projects are archived according to the data storage regulations and approvals. • Lead in the planning, designing, implementing and coordinating of the resources required to deliver the clinical trials e.g. design study documents, plan equipment, create and maintain study databases and spreadsheets. • Enter participant data into electronical databases. • Build relationships with study participants and their families to ensure effective communication for co-ordinating and planning study visits. • Keep all study documents up to date and ensure effective management of the investigator site file and participant files. • Prepare and manage monitoring visits ensuring actions are completed in a timely manner. • Process and ship study samples in compliance with regulations. • Ensure all team members are appropriately trained and delegated to carry out their assigned tasks. • Prepare funding applications at the request of the clinical research and operations manager. • Contribute to the academic output of the STRONG. You would be expected to be involved in the development of research ideas and contributing to publications. • • Be proactive in suggesting ways to improve the functioning of the STRONG. Publicise your trials within the academic community and deliver on-site training to staff at research sites. Selection criteria Essential • • • • • • • Educated to degree level or equivalent experience. Basic understanding of working in clinical trial management and having had responsibility for some tasks within the lifecycle of a trial. You will have worked on at least one study from setup to completion of recruitment. Excellent communication skills and the ability to deliver complex information in a concise way to varied audiences. Knowledge of the regulatory and governance requirements for UK clinical trials. Ability to manage multiple projects at one time with proven excellent organisational skills. Willingness to travel within the UK for site set-up activities. Experience in processing and shipping study samples. Department of Paediatrics Clinical Trial Manager Job Description 2 Desirable • Experience of managing projects in academic secondary care setting. • Higher degree in a medical science or equivalent experience. . Pre-employment screening Standard checks If you are offered the post, the offer will be subject to standard pre-employment checks. You will be asked to provide: proof of your right-to-work in the UK; proof of your identity; and (if we haven’t done so already) we will contact the referees you have nominated. You will also be asked to complete a health declaration so that you can tell us about any health conditions or disabilities for which you may need us to make appropriate adjustments. Please read the candidate notes on the University’s pre-employment screening procedures at: https://www.jobs.ox.ac.uk/pre-employment-checks Hazard-specific / Safety-critical duties This job includes hazards or safety-critical activities. If you are offered the post, you will be asked to complete a health questionnaire which will be assessed by our Occupational Health Service, and the offer of employment will be subject a successful outcome of this assessment. The hazards or safety-critical duties involved are as follows: • Working with blood, human products and human tissues • Work in clinical areas with direct contact with patients (NOT administrative roles) Additional security pre-employment checks This job includes duties that will require additional security pre-employment checks: • This role requires a research honorary NHS contract. The department will support the successful candidate in obtaining this where required and appropriate. • A satisfactory enhanced Disclosure and Barring Service check due to regulated activity involving children and ‘at risk’ adults • University security screening (e.g. identity checks) Department of Paediatrics Clinical Trial Manager Job Description 3 About the University of Oxford Welcome to the University of Oxford. We aim to lead the world in research and education for the benefit of society both in the UK and globally. Oxford’s researchers engage with academic, commercial and cultural partners across the world to stimulate high-quality research and enable innovation through a broad range of social, policy and economic impacts. We believe our strengths lie both in empowering individuals and teams to address fundamental questions of global significance, while providing all our staff with a welcoming and inclusive workplace that enables everyone to develop and do their best work. Recognising that diversity is our strength, vital for innovation and creativity, we aspire to build a truly diverse community which values and respects every individual’s unique contribution. While we have long traditions of scholarship, we are also forward-looking, creative and cuttingedge. Oxford is one of Europe's most entrepreneurial universities and we rank first in the UK for university spin-outs, and in recent years we have spun out 15-20 new companies every year. We are also recognised as leaders in support for social enterprise. The University of Oxford has recently published their New Ways of Working framework to ensure professional service staff can continue to support the University’s academic mission whilst working on site or remotely. For more information, please visit https://hr.admin.ox.ac.uk/newways-of-working Join us and you will find a unique, democratic and international community, a great range of staff benefits and access to a vibrant array of cultural activities in the beautiful city of Oxford. For more information, please visit www.ox.ac.uk/about/organisation. Specialised Translational Research Oxford Neuromuscular Group (STRONG) STRONG is led by Laurent Servais, Professor of Paediatric Neuromuscular Diseases. Staff are based within a suite of offices in the academic centre on the third floor of the John Radcliffe Hospital in Headington, Oxford. This rapidly growing research group focuses on paediatric neuromuscular diseases and driving research into early identification, potential treatments, and early intervention for rare disorders. Major focuses of the group include gene therapy – it is colead of a WP in a European Project to evaluate potential marker of gene therapy toxicity in humans – as well as neonatal genetic screening, with the implementation of the first genetic population-based screening in the UK for spinal muscular atrophy being one of its proudest recent achievements. The group is also leading an ambitious program of research into Angelman syndrome, with clinical trials and a natural history study ongoing. Department of Paediatrics Clinical Trial Manager Job Description 4 Department of Paediatrics The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. Our work spans from early proof-of concept fundamental science, all the way up to its application in clinical settings. We continue to shape the landscape of medical science through positively impacting the lives of millions of children from our global research programmes, academic resources, and commitment to success. Our broad research base positions the department in a pivotal role and subsequently a world leader in child health. With research facilitates in the UK and abroad, we work on a global scale, building a paediatric network in the medical science community. We are committed to inform and inspire external audiences worldwide through our public engagement and outreach activities. In 2021, we successfully administered a grant value of £130,895,28 obtained through 168 projects. Our strong relationship with funding bodies have also been a contributor to the successes and milestones in children’s health research. With strong support from the Wellcome Trust, NIH, Cancer Research UK, UKRI, MDUK, Bill & Melinda Gates Foundation, Academy of Medical Sciences and the NIHR, we have employed 360+ staff, researchers, and students. These figures continue to grow as we expand our activities to overcome the multitude of challenges within children’s research health. For more information please visit: http://www.paediatrics.ox.ac.uk/ The Department of Paediatrics holds a silver Athena Swan award to recognise advancement of gender equality: representation, progression and success for all. Medical Sciences Division We are an internationally recognized centre of excellence for biomedical and clinical research and teaching, and the largest academic division in the University of Oxford. World-leading programmes, housed in state-of-the-art facilities, cover the full range of scientific endeavour from the molecule to the population. With our NHS partners we also foster the highest possible standards in patient care. For more information please visit: http://www.medsci.ox.ac.uk/ Department of Paediatrics Clinical Trial Manager Job Description 5 How to apply Applications are made through our e-recruitment system and you will find all the information you need about how to apply on our Jobs website https://www.jobs.ox.ac.uk/how-to-apply. Your application will be judged solely on the basis of how you demonstrate that you meet the selection criteria stated in the job description. As part of your application you will be asked to provide details of two referees and indicate whether we can contact them now. You will be asked to upload a CV and a supporting statement. The supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This may include experience gained in employment, education, or during career breaks (such as time out to care for dependants) Please upload all documents as PDF files with your name and the document type in the filename. All applications must be received by midday UK time on the closing date stated in the online advertisement. Information for priority candidates A priority candidate is a University employee who is seeking redeployment because they have been advised that they are at risk of redundancy, or on grounds of ill-health/disability. Priority candidates are issued with a redeployment letter by their employing department(s). If you are a priority candidate, please ensure that you attach your redeployment letter to your application (or email it to the contact address on the advert if the application form used for the vacancy does not allow attachments). If you need help Application FAQs, including technical troubleshooting https://staff.web.ox.ac.uk/recruitment-support-faqs advice is available at: Non-technical questions about this job should be addressed to the recruiting department directly at recruitment@paediatrics.ox.ac.uk or using the contact details in the online advertisement. To return to the online application at any stage, please go to: www.recruit.ox.ac.uk. Please note that you will receive an automated email from our e-recruitment system to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. Department of Paediatrics Clinical Trial Manager Job Description 6 Important information for candidates Data Privacy Please note that any personal data submitted to the University as part of the job application process will be processed in accordance with the GDPR and related UK data protection legislation. For further information, please see the University’s Privacy Notice for Job Applicants at: https://compliance.admin.ox.ac.uk/job-applicant-privacy-policy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/data-protection-policy. The University’s policy on retirement The University operates an Employer Justified Retirement Age (EJRA) for very senior research posts at grade RSIV/D35 and clinical equivalents E62 and E82, which with effect from 1 October 2023 will be 30 September before the 70th birthday. The justification for this is explained at: https://hr.admin.ox.ac.uk/the-ejra. For existing employees on these grades, any employment beyond the retirement age is subject to approval through the procedures: https://hr.admin.ox.ac.uk/the-ejra. There is no normal or fixed age at which staff in posts at other grades have to retire. Staff at these grades may elect to retire in accordance with the rules of the applicable pension scheme, as may be amended from time to time. Equality of opportunity Entry into employment with the University and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. Department of Paediatrics Clinical Trial Manager Job Description 7 Benefits of working at the University Employee benefits University employees enjoy 38 days’ paid holiday, generous pension schemes, travel discounts, and a variety of professional development opportunities. Our range of other employee benefits and discounts also includes free entry to the Botanic Gardens and University colleges, and discounts at University museums. See https://hr.admin.ox.ac.uk/staff-benefits University Club and sports facilities Membership of the University Club is free for all University staff. The University Club offers social, sporting, and hospitality facilities. Staff can also use the University Sports Centre on Iffley Road at discounted rates, including a fitness centre, powerlifting room, and swimming pool. See www.club.ox.ac.uk and https://www.sport.ox.ac.uk/. Information for staff new to Oxford If you are relocating to Oxfordshire from overseas or elsewhere in the UK, the University's Welcome Service website includes practical information about settling in the area, including advice on relocation, accommodation, and local schools. See https://welcome.ox.ac.uk/ There is also a visa loan scheme to cover the costs of UK visa applications for staff and their dependents. See https://staffimmigration.admin.ox.ac.uk/visa-loan-scheme Family-friendly benefits With one of the most generous family leave schemes in the Higher Education sector, and a range of flexible working options, Oxford aims to be a family-friendly employer. We also subscribe to the Work+Family Space, a service that provides practical advice and support for employees who have caring responsibilities. The service offers a free telephone advice line, and the ability to book emergency back-up care for children, adult dependents and elderly relatives. See https://hr.admin.ox.ac.uk/my-family-care Childcare The University has excellent childcare services, including five University nurseries as well as University-supported places at many other private nurseries. For full details, including how to apply and the costs, see https://childcare.admin.ox.ac.uk/ Disabled staff We are committed to supporting members of staff with disabilities or long-term health conditions. For further details, including information about how to make contact, in confidence, with the University’s Staff Disability Advisor, see https://edu.admin.ox.ac.uk/disability-support Staff networks The University has a number of staff networks including the Oxford Research Staff Society, BME staff network, LGBT+ staff network and a disabled staff network. You can find more information at https://edu.admin.ox.ac.uk/networks The University of Oxford Newcomers' Club The University of Oxford Newcomers' Club is an organisation run by volunteers that aims to assist the partners of new staff settle into Oxford, and provides them with an opportunity to meet people and make connections in the local area. See www.newcomers.ox.ac.uk. Department of Paediatrics Clinical Trial Manager Job Description 8
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About the role We have an exciting opportunity to join the Specialised Translational Research Oxford Neuromuscular Group (STRONG) in the Department of Paediatrics as our Clinical Trial Manager. You will play an important role in the delivery of our portfolio of clinical trials and will work closely with the Clinical Research and Operations Manager, Laura Chiverton and the Principle Investigator, Laurent Servais. You will be responsible for the management and delivery of a portfolio of clinical trials and will work closely with the research group to ensure efficient running of our clinical trials. The successful candidate will have excellent organisational and communication skills to facilitate smooth delivery of our clinical trials. You will be working in a growing department within the Medical Sciences Division. The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. This position is offered full-time on a fixed-term contract initially for one year or until 31 December 2025 (whichever is sooner) with the possibility to extend provided further external funding is available. About the department The Department of Paediatrics holds the Athena Swan Gold award (a national gender equality charter) acknowledging the innovative policies and practices developed across the department. We encourage staff to develop their skills by offering all staff ten paid days of professional development each year and have a policy where staff can apply to receive funding for further training courses to support their professional development. For staff on work visas, we also offer financial assistance towards visa renewal fees. Please visit our website to find out more about the Department. About you You will have experience in management of clinical trials and be educated to degree level, or have equivalent experience. The successful candidate will have knowledge of the regulatory and governance requirements for UK clinical trials. You will have highly effective verbal and written communication skills with all levels of staff and an ability to operate effectively in a demanding and growing research environment. Application Process You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Laura Chiverton, the Clinical Research and Operations manager. Only online applications received before 12.00 midday on 15th November 2024 will be considered. Interviews will be held as soon as possible thereafter. The Department of Paediatrics offers an Interview Expense Reimbursement Policy in its efforts towards equality, diversity and inclusion. Should you be invited to interview, we will share further information about the policy at that stage.
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